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January 13, 2015, PLLR E-Newsletter

Plaintiffs seek MDL in Benicar litigation

Liane Leshne

Lawsuits are mounting over the blood pressure drug Benicar, which has been linked to serious gastrointestinal injuries, including sprue-like enteropathy—a condition that causes severe, chronic diarrhea and malnourishment, among other problems. Claims against Daiichi Sankyo, Inc., the New Jersey-based manufacturer, and Forest Laboratories, which sold the drug as part of a co-promotion agreement, allege that the companies aggressively marketed Benicar and several related drugs without testing them properly or warning of their dangers.

The first Benicar lawsuits were filed in Louisiana federal court and New Jersey state court in early 2014. Since then, more state claims and at least 15 federal lawsuits have been filed in various jurisdictions. The plaintiffs have moved for the creation of a multidistrict litigation (MDL) panel to centralize litigation and consolidate discovery.

The FDA approved Benicar to treat hypertension in 2002. That year, Daiichi Sankyo and Forest launched a massive marketing campaign to convince patients and the medical community that the drug’s active ingredient—olmesartan medoxomil—made it safer and more effective than other hypertension drugs in the same class of angiotension II receptor blockers (ARBs). Daiichi Sankyo reportedly spent $1 billion over six years, investing heavily in face-to-face meetings with doctors and other marketing campaigns touting Benicar and the company’s other olmesartan drugs—Benicar HCT, Azor, and Tribenzor—as superior to other ARBs. At the same time, plaintiffs allege, the company failed to perform clinical trials to determine Benicar’s effectiveness and safety. As a result, the plaintiffs contend, physicians remained unaware of the risk, misdiagnosing patients or recommending other treatments, when simply stopping the drug could have alleviated their symptoms. Although patients who develop sprue-like enteropathy generally improve after discontinuing Benicar, some suffer permanent intestinal damage.

The FDA ordered Daiichi Sankyo and Forest to cease making efficacy and safety claims about Benicar in 2006, concluding that the claims were unsubstantiated and that the companies’ marketing materials were false and misleading. In 2013, the agency issued a drug safety alert warning patients and physicians about Benicar’s link to sprue-like enteropathy and advising doctors that patients could develop the condition months or even years after starting the drug. The FDA also ordered changes to the drug’s labeling to include a warning about the gastrointestinal effects.

Annette Johnson suffered chronic diarrhea, acute anemia, and renal failure, among other problems, after taking Benicar. In her products liability suit against Daiichi Sankyo and Forest, Johnson charges that the defendants over-promoted the drug through direct-to-consumer advertising while concealing the risks, making it impossible for her physician to timely diagnose her condition. The lawsuit, which includes counts for fraud, negligent misrepresentation, and civil conspiracy, among other claims, also seeks punitive damages. (Johnson v. Daiichi Sankyo, Inc., No. 3:14-cv-02672 (N.D. Ohio filed Dec. 5, 2014).) In December, Johnson filed a motion seeking to centralize litigation in an MDL in Ohio.

Tara Sutton said she feels the MDL will prove helpful. “Plaintiffs believe that centralization of the olmesartan products liability cases before a single federal judge will provide the coordination necessary to achieve a successful resolution of this litigation on behalf of our clients,” Sutton said. She added that discovery will focus on issues such as “when the defendants first became aware of Benicar’s severe gastrointestinal effects and why they failed for 11 years to convey that risk to patients and doctors.”

The FDA estimates that in 2012, more than 10 million Benicar prescriptions had been dispensed to nearly 2 million patients, and researchers and trial lawyers fear that current cases are just the tip of the iceberg.

“We strongly believe there are thousands of patients out there who have used Benicar, Benicar HCT, Azor, or Tribenzor and experienced severe gastrointestinal problems from use of the drugs, said Chris Coffin. “However, many patients and doctors are still unaware of the connection between these drugs and the adverse GI symptoms.”